INDICATIONS

For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae.

DOSAGE AND ADMINISTRATION

PEDIAZOLE (erythromycin and sulfisoxazole) SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMICSULFONAMIDES IN THIS AGE GROUP.

For AcuteOtitis Media in Children: The dose of Pediazole (erythromycin and sulfisoxazole) can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of Pediazole (erythromycin and sulfisoxazole) should be administered in equally divided doses three or four times a day for 10 days.Pediazole (erythromycin and sulfisoxazole) may be administered without regard to meals.

The following approximate dosage schedules are recommended for using Pediazole (erythromycin and sulfisoxazole) :

Children: Two months of age or older

FOUR-TIMES-A-DAY SCHEDULE

Weight

Dose--every 6 hours

Less than 8 kg (<18 lbs)

Adjust dosage by body weight

8 kg (18 lbs)

1 / 2 teaspoonful (2.5 mL)

16 kg (35 lbs)

1 teaspoonful (5 mL)

24 kg (53 lbs)

1 1 / 2 teaspoonfuls (7.5 mL)

Over 32 kg (over 70 lbs)

2 teaspoonfuls (10 mL)

THREE-TIMES-A-DAY SCHEDULE

Weight

Dose--every 8 hours

Less than 6 kg (<13 lbs)

Adjust dosage by body weight

6 kg (13 lbs)

1 / 2 teaspoonful (2.5 mL)

12 kg (26 lbs)

1 teaspoonful (5 mL)

18 kg (40 lbs)

1 1 / 2 teaspoonfuls (7.5 mL)

24 kg (53 lbs)

2 teaspoonfuls (10 mL)

Over 30 kg (over 66 lbs)

2 1 / 2 teaspoonfuls (12.5 mL)

TO PATIENT: Shake before using. Oversize bottle provides shake space. Keep tightly closed. Store in the refrigerator. Use within 14 days. Unused portion should be discarded after 14 days.